Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Plus Blood Glucose Meter
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G113-211G9
- Basic UDI-DI Code
- B-G113-211G9
- Reference
- G113-211
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The On Call Plus Blood Glucose Meter is intended to work with On Call Plus Blood Glucose Strips for quantitative measurement of glucose in fresh capillary whole blood from the fingertip, forearm and palm to monitor daily blood glucose for individuals who have diabetes or are potentially at risk for diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
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